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The standards that are in effect since 1 December 2010, [4] are the Indian Pharmacopoeia 2010 (IP 2010). The Pharmacopoeia 2014 was released by Health Minister Ghulam Nabi Azad on 4 November 2013. [5] The Pharmacopoeia 2018 was released by Secretary, Ministry of Health & Family Welfare, Government of India. [5]
The Indian government has announced its plan to bring all medical devices, including implants and contraceptives under a review of the Central Drugs and Standard Control Organisation (CDSCO). Within the CDSCO, the Drug Controller General of India (DCGI) regulates pharmaceutical and medical devices and is positioning within the Ministry of ...
Many developed countries set up their pharmacovigilance programs following the Thalidomide scandal in the 1960s. [2] India set up its program in the 1980s. [2] This general concept of drug safety monitoring went through different forms, but the Central Drugs Standard Control Organisation established the present Pharmacovigilance Program of India in 2010. [2]
IPA was founded in August 1999 by Dilip G Shah and six Indian drugmakers: Cipla, Dr. Reddy's, Lupin, Piramal, Ranbaxy, and Wockhardt. [1] IPA was founded to promote the cause of generic drugs in India [2] and has since expanded to include 24 domestic pharmaceutical companies. [3] Sudarshan Jain is the current secretary general of the IPA. [4]
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The 1699 Edinburgh Pharmacopoeia. A pharmacopoeia, pharmacopeia, or pharmacopoea (from the obsolete typography pharmacopœia, meaning "drug-making"), in its modern technical sense, is a book containing directions for the identification of compound medicines, and published by the authority of a government or a medical or pharmaceutical society. [1]
World Health Organization building from the South-East, Geneva The International Pharmacopoeia (Pharmacopoeia Internationalis, Ph. Int.) is a pharmacopoeia issued by the World Health Organization [1] as a recommendation, with the aim to provide international quality specifications for pharmaceutical substances (active ingredients and excipients) and dosage forms, [2] together with supporting ...
The Drugs and Cosmetics Rules, 1945 has provisions for classification of drugs under given schedules and there are guidelines for the storage, sale, display and prescription of each schedule. [1] The Rule 67 details the conditions of licenses. The Rule 97 contains the labeling regulations. [3] The notable Schedules include: